This latest innovation in Differential Scanning Calorimetry (DSC), PEAQ-DSC from Malvern Instruments, has been created specifically for the regulated environment, for faster, more accurate characterisation of protein and biomolecule stability
The PEAQ-DSC delivers essential data to guide biopharmaceutical development, from protein engineering, through preformulation and process development, to formulation and manufacture of the final product.
The new system offers enables determination of the conditions that maximise the shelf-life of a biotherapeutic. This helps maximise yields of biotherapeutic compounds and supports the robust demonstration of batch-to-batch comparability or innovator to biosimilar comparability.
MicroCal PEAQ-DSC delivers unattended 24-hour operation, with automated data analysis. The system is network-ready and has built-in automated cleaning and self-validation protocols.
We see customers searching for powerful analytical systems that can deliver data that genuinely informs development.
The MicroCal PEAQ-DSC is available with full documentation and software support for Analytical Equipment Qualification, in line with USP and FDA guidance, as well as a package to aid technical compliance to FDA CFR Part 11 and EU GMP Annex 11.
Ronan O’Brien, Head of Business Development, MicroCal, at Malvern, said: “As the importance of biopharmaceuticals continues to grow, we see customers searching for powerful analytical systems that can deliver data that genuinely informs development, formulation and process decisions, as well as supporting regulatory challenges.
MicroCal PEAQ-DSC is available in two versions: a standalone instrument that includes the DSC cell and a dedicated computer, or a fully automated system with the addition of a liquid handling robot.